Kornimate/medical-research-clean huggingface dataset:
proteogenomic biomarker panels in a serial blood & urine monitoring study of kidney transplant recipients

Conditions: Kidney Transplant; Kidney Transplantation

Summary: there is a need to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had kidney transplant. researchers will examine blood, urine, and tissue samples and try to identify genetic markers for certain conditions like rejection, response to therapy, and scarring of the kidney. by studying gene patterns, researchers hope to be able to diagnose these conditions earlier and improve kidney survival.

kidney transplantation is a good treatment option for people with kidney disease. however, there is still much to learn about how to best care for the transplanted kidney and keep it working for a long time. one field of interest is how one's cellular make-up might affect the body's immune response (body's natural defense system to illness and foreign things) to a kidney transplant. cellular tests, like gene expression, help doctors to study a person's cellular traits. gene expression is when information found in one's dna is translated into rna and eventually proteins. these components are present in each of the body's cells. in this study, researchers are trying to learn if certain changes in the rna and proteins found in blood, urine, or transplant biopsy tissue can detect rejection before injury can occur or become too severe. the blood and urine tests will look for patterns in one's dna (called genetic markers). this study will follow subjects for 2 years after transplant. there will be a total of 12 study visits with additional study visits if rejection occurs. the study requires additional samples of blood, urine, and tissue to be collected during routine clinical visits and biopsies (a procedure to remove and examine a small piece of kidney tissue).

Eligibility criteria:
inclusion criteria: * subjects undergoing primary or subsequent deceased-donor or living donor kidney transplantation * subject and/or parent guardian must be able to understand and provide informed consent * female subjects of childbearing potential must have a negative pregnancy test within 6 weeks of study entry. exclusion criteria: * need for combined organ transplantation with an extra-renal organ and/or islet * recipient of previous non-renal solid organ and/or islet cell transplantation * infection with hepatitis c virus (hcv) or human immunodeficiency virus (hiv) * inability or unwillingness of a participant to give written informed consent or comply with study protocol * any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

Keywords: biomarkers proteogenomic profiling acute rejection chronic allograft nephropathy/interstitial fibrosis and tubular atrophy
a study to evaluate the efficacy, safety, and pharmacokinetics of abt-450 with ritonavir (abt-450/r) when given together with abt-333 and ribavirin (rbv) in treatment-naïve and non-responder subjects with genotype 1 chronic hepatitis c virus (hcv) infection

Conditions: Chronic Hepatitis C Infection; Hepatitis C; Hepatitis C Virus

Summary: the purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of abt-450 with ritonavir (abt-450/r) dosed in combination with abt-333 (also known as dasabuvir) and ribavirin (rbv) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis c virus (hcv) infection.

this was a phase 2a multicenter, open-label, sequential, 3-arm, combination treatment study of a regimen of abt-450/r/abt-333, and ribavirin (rbv) in hepatitis c virus (hcv) genotype 1-infected treatment-naïve participants and previous non-responders to pegylated interferon (pegifn)/rbv treatment.

Eligibility criteria:
inclusion criteria: * chronic hepatitis c virus (hcv) * treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin * males and females 18-65 years old * body mass index 18 to \< 35 kg/m\^2 * females must be postmenopausal for at least 2 years or surgically sterile exclusion criteria: * cirrhosis or extensive bridging fibrosis * history of cardiac disease * positive screen for certain drugs or alcohol * abnormal laboratory results * significant sensitivity to any drug * positive hepatitis b surface antigen or anti-human immunodeficiency virus antibody * use of strong cytochrome p450 3a (cyp3a), cytochrome p450 2c8 (cyp2c8), and organic anion transporting polypeptide 1b1 (oatp1b1) enzyme inducers or inhibitors within 1 month of dosing
"pontic-shield" technique in alveolar ridge preservation

Conditions: Tooth Extraction Status Nos; Bone Loss; Bone Resorption

Summary: alveolar bone resorption after dental extraction frequently leads to situations in which long-term function and esthetic success of rehabilitations with dental implants is a challenge. "pontic-shield" has been described as an alternative technique to maintain alveolar ridge after tooth extraction. the aim of this study is to analyze the effectiveness of "pontic-shield" technique in alveolar ridge preservation comparing to fresh socket and ridge preservation using deproteinized bovine bone and a porcine collagen membrane.

a three-arm randomized clinical study will be conducted: * group 1 (study group): ridge preservation with "pontic-shield" technique. * group 2 (positive control): ridge preservation with deproteinized bovine bone and porcine collagen membrane after tooth extraction. * group 3 (negative control): tooth extraction only (fresh socket). a cone-beam computed tomography will be performed prior to tooth extraction and 4 months postoperative. radiographic changes between before and after intervention will be evaluated to asses the effectiveness of "pontic-shield" technique.

Eligibility criteria:
inclusion criteria: * patient from 18 to 80 years old * patients who sign the informed consent * need to perform extraction from second premolar to second premolar in maxilla and mandible exclusion criteria: * tobacco consumption (more than 10 cigarettes per day) * severe systemic disease ( asa iii or iv - american society of anaesthesiology) * drug use that could interfere with alveolar bone healing * active periodontal disease * acute or chronic apical pathology of the tooth

Keywords: tooth extraction alveolar ridge preservation partial extraction therapies bone resorption
erenumab (amg 334) plus combined oral contraceptive drug interaction study in healthy females

Conditions: Headache, Migraine

Summary: a pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.

a pharmacokinetic (pk) drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen. all participants will receive an oral contraceptive containing progestin and estrogen throughout the duration of the study. participants will also receive a single dose of erenumab, administered by a healthcare provider in cycle 3. serial pk samples will be collected at specified time points to characterize the pk of the oral contraceptive progestin and estrogen components with and without the presence of erenumab. the study consists of three 28-day cycles and a follow-up period. the first 28 day cycle is an acclimation period when participants initiate oral contraception (cycle 1). during cycle 2 and 3 the pk of ethinyl estradiol (ee) and active metabolites of norgestimate (ie, norelgestromin \[ngmn\] and norgestrel \[ng\]) will be characterized following the last active dose of oral contraceptive in each cycle (cycle day 21). erenumab will be given in cycle 3 (cycle day 10); 24-hour pk characterization of norgestimate and ee metabolites will occur 11 days after administration of erenumab, which will maximize the potential for detecting a drug-drug interaction.

Eligibility criteria:
inclusion criteria: * healthy female ≥18 to ≤45 years old at the time of enrollment * regular monthly menstrual cycle during the last 12 months * good general health based on a medical history evaluation and physical examination * no clinically significant abnormalities in laboratory tests at screening * subject has provided informed consent/assent prior to initiation of any study specific activities/procedures exclusion criteria: * intolerance to any recent oral contraceptive in the last three (3) years, * female subjects with a positive serum pregnancy test at screening * female subjects not willing to inform her sexual partner of her participation in the clinical study * use of any over the counter or prescription medications within the 14 days or 5 half lives (whichever is longer) * nicotine use eg cigarettes or equivalent during 12 months prior to day 1 and through the duration of the study
effects of decompression in patient with acute vs chronic lumbar radiculopathy

Conditions: Lumbar Radiculopathy

Summary: the study will be done to evaluate the effectiveness of lumbar spinal decompression in patients with acute vs chronic lumbar radiculopathy. study design will be randomized control trial and sample size will be 30. duration of study was of 6 month, convenient sampling was done. data will be collected from dhq daska were randomly allocated in three groups via lottery method, baseline assessment was done. patients of both gender (male and female) from 18 to 50 years with lumbar radiculopathy diagnosed through x-ray and physical examination will be included. patients with systemic soft tissue and bony diseases will be excluded. intervention duration of 4 weeks, 3 sessions in a week. decompression of lumbar spine will be given once in a week. whole procedure of treatment program will given to patients and written informed consent will be taken. basic tools will be visual analog scale (vas), slr, odi, inclinometer. data was analyzed by using spss version 21

low back pain (lbp) is one of the most common musculoskeletal conditions treated by physical therapists. although lumbar traction is frequently used by physical therapists in the treatment of patients with lbp. we will use manual lumber spinal traction on patients with acute vs chronic lumber radiculopathy. the current study will determine the effect of decompression in relieving pain, increase range of motion and improving function in patients of acute and chronic lumbar radiculopathy. lumbar traction (lt) is routinely used on its own or in conjunction with other treatments for the management of lumbar sciatica. we will use manual lumbar traction along with hot pack, tens, mobilization and exercise therapy. intervention duration of 4 weeks, 3 sessions in a week. decompression of lumbar spine will be given once in a week.

Eligibility criteria:
inclusion criteria: * history of radicular pain with straight leg raise (slr). * patients in the acute phase of (up to 6 weeks) included in group a * patients in chronic phase of (more than 6 weeks) included in group b exclusion criteria: * any systemic soft tissue and bony disease. * patient with spinal tuberculosis, spinal fractures, pregnancy, cancer. * any recent surgery. * patient with any cervical or thoracic problem. * patients with any other serious pathology/red flags

Keywords: decompression, radiculopathy, acute, chronic
application of new technologies and tools to nutrition research

Conditions: Obesity; Diabetes

Summary: the overall objective of the research is to develop new methods for studying the link between diet, health and disease.

the enquiry consists of two part. a metabolomic biomarker discovery study followed by a randomised controlled trial of moderate dietary induced weight loss. a cohort of moderately overweight men and women will undergo a metabolomic study follow by randomised controlled trial of a healthy diet with a 20% energy restriction for a 12 week period. this intervention will improve the volunteer's body composition and reduce their risk of developing diabetes. extensive tests will be conducted before and after the dietary intervention using emerging technologies with current state-of-the-art methods. these tests will monitor the numerous physiological adaptations that have occurred on a gene, cell, organ and organismic level. the study will, therefore, aim for a scientific breakthrough by developing a series of novel biological "markers" that can accurately determine an individual's health status.

Eligibility criteria:
inclusion criteria: * healthy overweight volunteers (body mass index (bmi) of 25-30 kg/m2) * age between 50-65 years exclusion criteria: * weight change of ≥ 3kg in the preceding 3 months * current smokers * substance abuse * excess alcohol intake * pregnancy * diabetes * cardiovascular disease * cancer * gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome * kidney disease * liver disease * pancreatitis * have any metallic or magnetic implants such as pacemakers * use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.

Keywords: obesity metabolites
brief intervention and referral to treatment with substance use disorders in the emergency room setting

Conditions: Substance Use

Summary: this study will be a quality improvement project to review the effectiveness and barriers to effectiveness of a new clinical program in the emergency room to provide substance use screening followed by brief motivational interviewing and referral to treatment for patients who meet criteria for problem substance use. this study will consist of a chart review of the results of the screens performed by substance use counselors and correlating them to institutional variables such as wait time in the emergency room and length of stay as well as to patient variables obtained by chart review such as medical diagnosis and sociodemographic variables.


Eligibility criteria:
inclusion criteria: * age 19 and older presentation to uab emergency department exclusion criteria: * younger than 19 prisoners

Keywords: substance use treatment
neurophysiologic maturation index for moderate and late preterm infants

Conditions: Neurophysiologic Maturation

Summary: moderate and late preterm infants contribute to significant neonatal intensive care unit health care resource utilization because of their sheer numbers. determinants of the length of hospitalization (loh) in this population are understudied. gestational age (ga) is used most commonly as a predictor for loh but there are many limitations including inaccurate dating and morbidities of prematurity which at least partly related to neurophysiological immaturity. the latter can be assessed by amplitude integrated electroencephalogram (aeeg, a simplified 5 lead eeg), and possibly by heart rate variability (hrv) and respiratory variability (rv). all 3 are non-invasive tests that can be done at the bedside. our study hypothesis is to determine if neurophysiologic maturation as assessed by aeeg, hrv and rv within 24-96 hours following birth improves the correlation between gestational age and length of hospitalization compared to gestational age alone.


Eligibility criteria:
inclusion criteria: * gestational age of either 320-326 weeks or 340-346 weeks by obstetric criteria (presence of a sure lmp or sonogram performed in the first trimester, or agreement between lmp and a sonogram performed between the first trimester and 20 weeks) * admitted to a nicu of a participating institution * post-natal age less than 96 hours exclusion criteria: * major congenital anomaly/genetic anomaly * growth restriction (birth weight \< 10%, fenton growth curves) * unsure obstetric dating (e.g., absence of a sure lmp without a sonogram, earliest sonogram performed after 20 weeks without a sure lmp, or discrepancy between lmp and sonogram) * exposure to medications within the preceding 12 hrs which may affect cns function (e.g., fentanyl, morphine, midazolam) * neonatal seizures * neonatal abstinence syndrome secondary to in-utero exposure to narcotics, methadone etc, or at high risk for development of abstinence * hypoxia-ischemia defined as the combination of fetal acidemia (cord gas or blood gas within 1 hour of birth: ph ≤ 7.15 or be ≥ -10meq/l), need for resuscitation at birth (ppv ± chest compressions or medications), and evidence of encephalopathy (stage 1, 2 or 3 sarnat). stage 1 encephalopathy will be defined based on the level of consciousness which is characterized by a hyper-alert state, apparent alertness, and irritability. in the absence of a cord or early post-natal blood gas, there must be a history of a perinatal event which may have compromised oxygenation or blood flow to the fetus. * infants who are expected to be on mechanical (via an endotracheal tube) or high frequency ventilation for the first 96 hours after birth. * inability to obtain the informed consent

Keywords: amplitude integrated electroencephalogram heart rate variability respiratory rate variability preterm infants length of hospital stay
effects of self-mobilization techniques in chronic thoracic pain

Conditions: Thoracic

Summary: a randomized clinical trial will be conducted at actilife physiotherapy rehabilitation center, horizon hospital lahore through a convenient sampling technique on patients who will be allocated using simple random sampling through sealed opaque enveloped into group a and group b. group a will be treated with the self-mobilization technique of thoracic spine and group b will be treated with thoracic stretching exercises at a frequency of 2 sets with 6 repetitions and thrice a week. outcome measures will be nprs, goniometer, and oswestry disability index for thoracic spine after 6 weeks. data will be analyzed during spss software version 21.

chronic thoracic pain is pain that originates from the cervicothoracic junction and extends to the lower thoracic vertebrae. it is caused by strain in the thoracic spine area, sustained postures of the neck and thoracic region, sitting on the computer for a long time in slouched position, or overuse of the thoracic spine. this study aims to see the effects of the self-mobilization technique of the thoracic spine on pain, range of motion, and function in patients with chronic thoracic spine pain. a randomized clinical trial will be conducted at actilife physiotherapy rehabilitation center, horizon hospital lahore through a convenient sampling technique on patients who will be allocated using simple random sampling through sealed opaque enveloped into group a and group b. group a will be treated with the self-mobilization technique of thoracic spine and group b will be treated with thoracic stretching exercises at a frequency of 2 sets with 6 repetitions and thrice a week. outcome measures will be nprs, goniometer, and oswestry disability index for thoracic spine after 6 weeks. data will be analyzed during spss software version 21. after assessing normality of data by shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility criteria:
inclusion criteria: * chronic thoracic pain minimum 3 months exclusion criteria: * soft tissues disease * bony disease * surgical history of thoracic spine * fracture history of thoracic spine * tumor * psychological disorders * traumatic injury

Keywords: manual therapy pain range of motion
impact of the preventive emotions management questionnaire on the rates of isolation and mechanical restraint measures in the psychiatric admission unit

Conditions: Psychiatric Disorder

Summary: this observational study assesses whether the use of the qpge has an impact on the rates of isolation and mechanical restraint in adult psychiatric admission units. it is supplemented by a qualitative survey that will collect the experience of caregivers using the qpge.

the use of isolation and mechanical restraint in psychiatry has deleterious consequences for the patient. caregivers also testify to their dissatisfaction with using these methods. the coping agreement questionnaire (caq) is a form presented to the patient admitted to a psychiatric unit in the united states that has shown a significant effect on the reduction of coercive measures. it has been translated into french under the name questionnaire préventif de la gestion des emotions (qpge). in france, the haute autorité de santé has been recommending this type of tool since 2016 in the form of shared prevention plans to better prevent moments of violence. the main objective is to assess whether the use of a shared prevention plan based on the preventive emotions management questionnaire (qpge) can reduce the rates of isolation measures and mechanical restraint in hospitalized people. in a sectoral admission unit receiving patients in care without consent.

Eligibility criteria:
inclusion criteria: * have been hospitalized in psychiatric admission unit with an entry date between january 1, 2020 and december 31, 2020 * be at least 18 years old at the time of hospitalization * master the french language in order to have benefited from the qpge and the satisfaction questionnaire exclusion criteria: * being the subject of an isolation and/or restraint measure, decided in another unit before, during the transfer to the study places * to have objected to the use of data collected during hospitalization following the information in the welcome booklet

Keywords: psychiatric disorder prevention mechanical restraint isolation
dha and vitamin d in children with biopsy-proven nafld

Conditions: NAFLD; Non Alcoholic Steatohepatitis (NASH)

Summary: non-alcoholic fatty liver disease (nafld) has reached epidemic proportions and is rapidly becoming the one of most common causes of chronic liver disease in children. the pathogenesis of nafld is generally considered the result of a series of liver injuries, commonly referred as "multi-hit" hypothesis. several studies suggest that inflammatory pathways and oxidative stress could be responsible of disease progression. the purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (dha) and vitamin d in children and adolescents with biopsy-proven nonalcoholic fatty liver disease (nafld).

sixty-six children or adolescents (4-16 years) with liver biopsy proven nafld will be enrolled. they will be randomized to treatment with dha and vitamin d (n=33) or an identical placebo (n=33) given orally for a period of 6 months. all patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise. patients will undergo a medical evaluation at 3-6 and 12 months during the 12-months study period. liver biopsy will be performed at baseline and at 12 months. anthropometric measurements and laboratory tests, including liver enzymes, gluco-insulinemic profile and lipids will be performed at baseline and repeated at 6-12 months

Eligibility criteria:
inclusion criteria: * biopsy consistent with the diagnosis of nafld/nash * reduced serum levels of vitamin d aminotransferases (alt) levels \<10 upper limit of normal * hyperechogenicity at liver ultrasound examination suggestive of fatty liver * international normalized ratio (inr) \< 1,3 * albumin \> 3 g/dl * total bilirubin \< 2,5 mg/dl * no previous gastrointestinal bleeding * no previous portosystemic encephalopathy * normal renal function * no hepatitis b, hepatitis c infection * normal cell blood count exclusion criteria: * alcohol consumption * use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism * autoimmune liver disease, metabolic liver disease, wilson's disease, and a-1-antitrypsin-associated liver disease * every clinical or psychiatric disease interfering with experimentation according to investigator's evaluation * finding of active liver disease due to other causes

Keywords: nafld nash dha vitamin d obesity children